Job Information

University of Utah PS Clinical Site Monitor in Salt Lake City, Utah

Details

Open Date 09/24/2021

Requisition Number PRN27771B

Job Title PS Clinical Site Monitor

Working Title PS Clinical Site Monitor

Job Grade F

FLSA Code Administrative

Patient Sensitive Job Code? Yes

Standard Hours per Week 40

Full Time or Part Time? Full Time

Shift Day

Work Schedule Summary

Monday – Friday, 9:00 am – 5:00 pm. Occasional weekends required as necessary.

VP Area U of U Health - Academics

Department 01643 - CLINICAL TRIALS OFFICE

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range $47,600 to $79,699

Close Date

Open Until Filled Yes

Job Summary

This position offers an exciting opportunity to be part of a collaboration with Clinical and Translational Science Institute ( CTSI ), Clinical Research Support Office ( CRSO ) and the Department of Pediatrics. This role is responsible for overseeing, coordinating and conducting audits of multiple clinical research projects within the University of Utah and other clinical sites. Position provides independent regulatory oversight of all aspects of study conduct at the site, institutional, or network level. Ensures compliance with University policies, Food and Drug Administration ( FDA ) and Office of Human Research Protection ( OHRP ) regulations, Good Clinical Practice ( GCP ), and state and federal guidelines. Expertise in human subject research and experience working with the FDA and ICH GCP are required. Must have the ability to Independently perform all on-site or remote monitoring activities.

The University of Utah offers a comprehensive benefits package with excellent health care options, 14.2% retirement contributions that vest immediately, a variety of retirement plans, and generous paid leave time. Current benefits information is available at www.hr.utah.edu/benefits .

Responsibilities

1. Monitors clinical studies in accordance with FDA regulations, ICH guidelines, IRB policies, protocol specifications and monitoring plan. Reviews investigational product or device accountability site records for accuracy. Analyzes and documents audit findings and creates monitoring reports.

2. Reviews site monitoring reports and discusses findings with clinical trial teams and study Investigators. Provides guidance for appropriately returning the clinical study to full regulatory compliance.

3. Works in collaboration with the Office of Research Integrity and Compliance, Huntsman Cancer Institute and Internal Medicine along with other Departments campus wide to develop campus-wide processes and procedures.

4. Works directly with Principal Investigators during protocol development. Provides in-depth review of and suggestions for investigator-initiated trial ( IIT ) protocols. Assists in drafting study monitoring and DSMC plans.

5. Works closely with the rest of QA team to develop, monitor, and update quality control systems for tracking compliance activities. Identifies issues, trends, and risk areas. Recommends improvements to operating policies and procedures.

6. Develops, coordinates, and participates in educational and training programs to promote compliance and enhance awareness of compliance issues. Conducts in-person training on an individual, department, institutional, and multi-institutional level.

7. Teams up with faculty and staff to assist investigators, sites, divisions and departments in implementing compliance practices and monitors and coordinates those activities with the departments.

Minimum Qualifications

Bachelor’s degree in a health science or related field or equivalency; and four years of clinical research experience that includes regulatory compliance monitoring/auditing, IRB application submission, and experience in human subjects research. Must have a working knowledge of FDA , ICH , and other regulatory compliance; an understanding of medical terminology and technical writing experience. Excellent interpersonal communication (including oral and written) and leadership skills also required. Must be proficient in Microsoft Office and possess the ability to learn new software programs.

This position is patient-sensitive and must fulfill all associated requirements. We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.

Preferences include credentialing as a Certified Clinical Research Associate ( CCRA ), Certified Clinical Research Coordinator ( CCRC ), and/or Certified Clinical Research Professional ( CCRP ). Prior experience as an industry CRA or Monitor is also preferred.

Hiring department may require certification by an appropriate certifying body within two years of hire.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Preferences

  • Prior experience with Institutional Review Board ( IRB ) procedures and protocol development.
  • Ability to write clear and concise reports and present information effectively in various communication settings.
  • Experience with providing training and education.
  • Strong interpersonal and customer service skills.
  • Availability to travel locally and nationally multiple days at a time to initiate and conduct monitoring of national multi-center trials.

Applicants will be screened according to preference.

Type Benefited Staff

Special Instructions Summary

Additional Information

The University of Utah values candidates who have experience working in settings with students from diverse backgrounds and possess a strong commitment to improving access to higher education for historically underrepresented students.

Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities and protected veterans are encouraged to apply. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities.

The University of Utah is an Affirmative Action/Equal Opportunity employer and does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy-related conditions, genetic information, or protected veteran’s status. The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106. The requirement not to discriminate in education programs or activities extends to admission and employment. Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both.

To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Affirmative Action:

Director/ Title IX Coordinator

Office of Equal Opportunity and Affirmative Action ( OEO /AA)

135 Park Building

Salt Lake City, UT 84112

801-581-8365

oeo@utah.edu

Online reports may be submitted at oeo.utah.edu

For more information: https://www.utah.edu/nondiscrimination/

To inquire about this posting, email: employment@utah.edu (%20employment@utah.edu) or call 801-581-2300.

The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work). Contact Human Resources at (801) 581-7447 for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS’ post-retirement rules and restrictions. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules.

This position may require the successful completion of a criminal background check and/or drug screen.